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Paladin Medical Inc

United States

Overview

Paladin Medical, Inc. has over two decades of award-winning service to the medical device industry. Specializing in a full range of regulatory, clinical and technical contract services, we guide our clients through the rapidly changing worldwide regulatory environment. Specific services include support of design control and review, setting up a basic quality system, animal study protocol and study management, clinical trial design and management, submission strategy and preparation, interface with FDA for planning and submission management, post-market reporting and quality system gap analysis. The hands-on engineering, development, and executive management experience that Paladin Medical can provide is unmatched in today's world of regulatory consulting. In order to maintain quality service to our clients, we place high value on the importance of continuing education by staying current on new regulations, FDA guidance documents, national and international standards and best practices. Our extensive product experience, in conjunction with our commitment to high standards, has resulted in countless successful product submissions and robust compliance training for our clients. In short, our unparalleled standards make us your Champion for Product Success. PLEASE CONNECT WITH PALADIN MEDICAL IF YOU 'Have a new medical device that needs clinical testing 'Need guidance in Design Control and Review 'Need strategic planning for regulatory approval 'Have questions on selecting biomaterials or testing for biocompatibility 'Need guidance on risk management and hazard analysis 'Need customized medical device training 'Need a quality system regulatory procedures ' SPECIALTIES ' Artificial Hearts, Heart Assist and Heart Valves ' Polymer Biomaterials, Surface Modifications and Combination Products ' Bone Graft Substitutes, Restorative Materials and Devices, Implants ' Electrophysiology ' Cardiovascular and Neurological ' Minimally Invasive Technology

Areas of subspecialty

483 responses
Warning Letter Responses
Remediation Strategies
Labeling and Website Reviews
Audits and Gap Analyses
Mock FDA Inspections
Regulatory Submissions
Areas of service
  • North America